Study Evaluating Temsirolimus (CCI-779) In Breast Neoplasms

Wyeth

Status and phase

Completed

Phase 2

Conditions

Breast Neoplasms

Treatments

Drug: Letrozole / Temsirolimus (CCI-779)

Drug: Letrozole

Study type

Interventional

Funder types

Industry

Identifiers

NCT00062751

B1771005

3066A1-204

Details and patient eligibility

About

To evaluate the preliminary activity and pharmacokinetics of 2 separate doses and schedules of orally administered Temsirolimus (CCI-779) given in combination with daily letrozole, compared to letrozole alone, in the treatment of locally advanced or metastatic breast cancer in postmenopausal women. All patients must be appropriate to receive endocrine therapy as treatment for advanced disease.

Enrollment

108 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Postmenopausal women with histologically confirmed, measurable locally advanced disease or metastatic breast.
Must be appropriate to receive endocrine therapy as treatment for advanced disease (chemotherapy; prior adjuvant therapy with antiestrogens other than aromatase inhibitors; prior adjuvant or first-line metastatic therapy with tamoxifen or trastuzumab, are permitted).
Women may either present with de novo advanced or metastatic cancer, or have had tumor progression while receiving adjuvant tamoxifen or at any time after completing adjuvant tamoxifen, or have had tumor progression while receiving first-line metastatic therapy with tamoxifen.

Exclusion criteria

Patients having known central nervous system (CNS) metastases.
Prior therapy with Temsirolimus (CCI-779) or aromatase inhibitors.
Tamoxifen, or other hormonal therapy, in the metastatic or adjuvant setting within 1 week prior to day 1 of treatment on study.